Revive Therapeutics Ltd (CSE:RVV, OTCQB:RVVTF) has revealed that the independent Data and Safety Monitoring Board (DSMB) meeting for its Bucillamine Phase 3 clinical trial for COVID-19 is scheduled for May 10, 2023.
The meeting will assess the efficacy of Bucillamine in the study’s post-dose selection data under the current protocol primary endpoint. The company expects to announce the DSMB’s recommendation by May 17, 2023.
In a statement, Revive CEO Michael Frank said: “We are eagerly awaiting the DSMB meeting and recommendation on our Bucillamine Phase 3 clinical trial for COVID-19. We believe that Bucillamine has great potential as a treatment option for infectious diseases, including COVID-19.”
The DSMB will recommend either continuing the study if there is a trend toward achieving statistical significance or halting the study early due to statistical significance likely not being met.
If the DSMB recommends continuing the study, Revive will evaluate the current COVID-19 environment and the likelihood of obtaining hospitalizations for the remainder of the study. The company may also seek a pharmaceutical partner to support the continuation of the study.
If the DSMB recommends not pursuing the study, the company will seek an evaluation of COVID-19 clinical symptoms data and determine a suitable regulatory approval pathway for Bucillamine in the US and internationally.
Revive is focused on the development of therapeutics for infectious diseases and rare disorders, and has been awarded several regulatory incentives by the US Food and Drug Administration (FDA).
The company's cannabinoid pharmaceutical portfolio focuses on rare inflammatory diseases, and the company has been granted FDA orphan drug status designation for the use of Cannabidiol to treat autoimmune hepatitis and ischemia and reperfusion injury from organ transplantation.
Revive has also acquired Psilocin Pharma Corp to develop psilocybin-based therapeutics for various diseases and disorders.
Contact the author at jon.hopkins@proactiveinvestors.com